Malignant NeoplasmRITNCT02696447
Radiation Impact on Thromboembolic Events
An observational study of Malignant Neoplasm, run by Institut de Cancérologie de la Loire at 2 sites in France.
Trial summary
The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Biomarkers assays
- How many people
- 450 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jun 2016to 25 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with a solid (all locations) treated with radiation therapy and / or brachytherapy as curative intent
Who may be able to join
- patient with a solid cancer (all locations) treated with radiation therapy and / or brachytherapy as curative intent
- to be 18
Who cannot join
- Patient with metastatic cancer,
- Patients whose follow-up at 6 months is not possible
- Patient receiving an anti-coagulative medication (curative doses)
- Pregnant or breastfeeding women,
- Person under protection of justice or unable to give consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH de Roanne
Roanne
Institut de cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
About this study
Official title: Radiation Therapy and Venous Thromboembolic Events
The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.
- Conditions
- Malignant Neoplasm
- Being tested
- Biomarkers assays
- Keywords
- Radiation therapy, Thrombosis
- Medical subject headings
- Neoplasms, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers assaysBiological
D-Dimer assays, C-reactive protein, blood platelets assays
| Study group | Role | What they receive |
|---|---|---|
| Cancer treated by radiotherapy | Patient with a solid cancer (all locations) treated with radiation therapy and/or brachytherapy as curative intent Receives: Biological: Biomarkers assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Thromboembolism event
All venous thromboembolism, whether symptomatic or discovered incidentally, objectified (CT angiography, lung scintigraphy, venous Doppler) between J1 of radiation treatment, up to 6 months following discontinuation of radiation treatment
Measured: 6 months
Secondary outcomes (5)
Dosage of D-dimer
Measured: 6 months
C-reactive protein
Measured: 6 months
Complete blood count
Measured: 6 months
Time of occurrence of VTE
Time of occurrence of VTE
Measured: 6 months
Symptomatic VTE
Symptomatic VTE.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start14 Jun 2016
- Primary completion24 Dec 2018
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, CH Roanne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696447
- Sponsor's protocol ID
- 2015-09
- Acronym
- RIT
- Status last verified
- Jan 2020
- First submitted
- 25 Feb 2016
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Daguenet E, Maison M, Tinquaut F, Giroux EA, Bertoletti L, Suchaud JP, Rancoule C, Guy JB, Magne N. Venous thromboembolism and radiation therapy: The final radiation-induced thrombosis study analysis. Cancer Med. 2022 Apr;11(8):1753-1762. doi: 10.1002/cam4.4559. Epub 2022 Feb 24.
PubMed 35199492
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy and Venous Thromboembolic Events
- ClinicalTrials.gov ID
- NCT02696447
- Acronym / sponsor ID
- RIT / 2015-09
- Conditions
- Malignant Neoplasm
- Keywords
- Radiation therapy, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, CH Roanne
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer treated by radiotherapy | – | Biological: Biomarkers assaysPatient with a solid cancer (all locations) treated with radiation therapy and/or brachytherapy as curative intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with a solid (all locations) treated with radiation therapy and / or brachytherapy as curative intent
Key inclusion criteria (2 listed)
- patient with a solid cancer (all locations) treated with radiation therapy and / or brachytherapy as curative intent
- to be 18
Key exclusion criteria (5 listed)
- Patient with metastatic cancer,
- Patients whose follow-up at 6 months is not possible
- Patient receiving an anti-coagulative medication (curative doses)
- Pregnant or breastfeeding women,
- Person under protection of justice or unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers assaysD-Dimer assays, C-reactive protein, blood platelets assays | Biological | Cancer treated by radiotherapy |
Primary outcome
Venous Thromboembolism event
Time frame: 6 months
All venous thromboembolism, whether symptomatic or discovered incidentally, objectified (CT angiography, lung scintigraphy, venous Doppler) between J1 of radiation treatment, up to 6 months following discontinuation of radiation treatment
5 secondary outcomes
Dosage of D-dimer
Time frame: 6 months
C-reactive protein
Time frame: 6 months
Complete blood count
Time frame: 6 months
Time of occurrence of VTE
Time frame: 6 months
Symptomatic VTE
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 35199492Daguenet E, Maison M, Tinquaut F, Giroux EA, Bertoletti L, Suchaud JP, Rancoule C, Guy JB, Magne N. Venous thromboembolism and radiation therapy: The final radiation-induced thrombosis study analysis. Cancer Med. 2022 Apr;11(8):1753-1762. doi: 10.1002/cam4.4559. Epub 2022 Feb 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by Institut de Cancérologie de la Loire at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Thromboembolism event (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.